ES2397010T3 - Implantable device with electrolytically separable junction that has multiple thin wires - Google Patents

Abstract

A set (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800), comprising: an implantable device (130, 1520); a conductive deployment mechanism (120, 1510) to deliver the implantable device; and an electrolytically separable joint (110) that couples the implantable device (130, 1520) to the conductive deployment mechanism (120, 1510), characterized in that the electrolytically separable joint (110) comprises a plurality of thin cables (210, 210a, 210b, 210c, 210d) which are separable from the implantable device (130, 1520) by means of the transmission of electric current (2020) therethrough.

Description

Implantable device with electrolytically separable junction that has multiple thin wires

Field of the Invention

The invention relates, in general, to implantable devices and, more particularly, to electrolytically separable, temporary joining members.

Background

Implants, such as vaso-occlusives, have been used in various applications including the treatment of intravascular aneurysms. A known vaso-occlusive device is a spiral spiral wound helically. A known spiral is formed by winding a platinum twisted cable over a primary mandrel and applying heat to the mandrel to impart a primary spiral winding form. The device is then wound around a secondary mandrel, and heat is applied to the secondary mandrel to impart a secondary shape. US Patent Nos. 4,994,069 and 5,354,295 provide examples of known vaso-occlusive spirals and spiral deployment procedures for treating aneurysms.

US Patent No. 5,354,295 describes a device and an embolism formation method that employs an electrolytically separable joint. A platinum spiral is delivered to a vascular cavity, such as an aneurysm, using a catheter and a deployment mechanism, such as a pusher or core cable, that has a stainless steel spiral or joint attached to the distal end thereof. After the vaso-occlusive spiral in its primary form has been placed in the aneurysm, a small electrical current is applied to the core wire to form a clot, which forms a thrombus or collagenous mass that contains the vaso-occlusive device in the same. The vaso-occlusive spiral is separated from the core cable by electrolysis, in which the electric current applied to the core cable dissolves the spiral or stainless steel joint that is exposed to the blood and fixed to the distal end of the core cable, with which separates the vaso-occlusive spiral at the place of the aneurysm. The core wire and the catheter can then be retracted, leaving the vaso-occlusive spiral in the aneurysm.

Summary

According to one embodiment, an assembly includes an implantable device, a conductive deployment mechanism and an electrolytically separable joint member between the deployment mechanism and the implantable device. The deployment mechanism is used to deliver the implantable device to a desired location. The electrolytically separable connecting member includes a plurality of thin cables that extend between the implantable device and the conductive deployment mechanism, so that when electrical current is applied to the thin cables through the conductive deployment mechanism, the thin cables are electrolyzed and separated from the implantable device.

According to another embodiment, a set includes an implantable vaso-occlusive spiral, a conductive deployment mechanism and an electrolytically separable joint member. The deployment mechanism is used to deliver the vaso-occlusive spiral in a desired location. The electrolytically separable connecting member includes a plurality of thin stainless steel cables having a diameter of approximately 12.7 μm (0.0005 "), such that when the electric current is applied to the thin stainless steel cables through From the conductive deployment mechanism, the thin stainless steel cables are electrolyzed and separated from the vaso-occlusive spiral.

According to a further alternative embodiment, an assembly includes an implantable vaso-occlusive spiral, a conductive deployment mechanism and an electrolytically separable joint member. The electrolytically separable joint member includes a plurality of thin stainless steel cables having a diameter of approximately 12.7 μm (0.0005 ") and a length of approximately 25.4 μm (0.01"). Each thin stainless steel cable is partially coated with a non-conductive coating. A first proximal portion of each wire is bare. A second portion adjacent to the first portion is coated with the non-conductive coating. A third portion adjacent to the second portion is bare. A fourth portion, adjacent to the third distal portion is coated with the non-conductive coating. The deployment mechanism is used to deliver the vaso-occlusive spiral to a desired location. When the electric current is applied to the proximal end of the thin stainless steel cables through the conductive deployment mechanism, the cables are electrolyzed and separated from the vaso-occlusive spiral.

In various embodiments, the connecting member may include cables made of materials, such as stainless steel, that can be electrolyzed. The connecting member may include different numbers of cables, for example, approximately two to ten cables and a greater number of cables, for example, as many as 500 or more thin cables. All cables can have the same diameter or different diameters. For example, a connecting member may include approximately 20 cables, and the diameter of some or all cables may be approximately 12.7 μm (0.0005 "). A cross-sectional surface area of the group of thin cables may be approximately 25.35 cm2 (3.93 x 10-6 inch2) In a separation zone with a length of 21.54 μm (0.010 ") that includes approximately 20 thin cables, the cylindrical surface area of all cables Thin can be approximately 20.26 x 10-4 cm2 (3.14 x 10-4 inch2). The thin cables can extend freely between the deployment mechanism and the implantable device or they can be rolled or twisted. The thin cables may also be partially covered for connection with the deployment mechanism and with the implantable device. For example, the proximal ends of the thin cables may be bare and connected by a conductive connection, such as solder or conductive polymer, to the conductive deployment mechanism. This allows current to circulate through the deployment mechanism and thin cables. The distal ends of the thin cables can be coated with a non-conductive coating and can be inserted into a non-conductive barrier member, such as a polymer barrier member, of the implantable device.

Brief description of the drawings

Referring below to the drawings, in which the same reference numbers represent corresponding parts in all of them:

Figure 1 illustrates, in general, an embodiment of an assembly having an electrolytically separable joint having a plurality of thin cables that are attached to a deployment mechanism and an implantable device;

Figure 2 illustrates an electrolytically separable joint having two thin wires in accordance with one embodiment;

Figure 3 illustrates an electrolytically separable joint having two thin wires and connected to a deployment mechanism and an implantable device using welding in accordance with one embodiment;

Figure 4 illustrates an electrolytically separable joint having two thin wires and is welded to a deployment mechanism and an implantable device according to one embodiment;

Figure 5 illustrates an electrolytically separable joint having two thin wires and is welded to a deployment mechanism and an implantable device according to one embodiment;

Figure 6 is a view of the embodiment shown in Figures 4 and 5, taken along the line A-A;

Figure 7 illustrates, in general, thin cables having several bends and elbows;

Figure 8 illustrates, in general, an embodiment of an electrolytically separable joint having more than two thin wires;

Figure 9 is a view of the embodiment shown in Figure 8, taken along the line B-B;

Figure 10 illustrates, in general, an embodiment of an electrolytically separable joint having multiple thin wires that are wound or stranded in accordance with one embodiment;

Figure 11 is a view of the embodiment shown in Figure 10, taken along the line C-C;

Figure 12 illustrates, in general, an electrolytically separable joint having thin wires of different sizes that are wound or stranded in accordance with one embodiment;

Figure 13 is a view of the embodiment shown in Figure 12, taken along the line D-D;

Figure 14 illustrates a thin cable that is partially coated in accordance with one embodiment;

Figure 15 illustrates an assembly according to an embodiment that includes an electrolytically separable joint having two thin wires extending between a pusher wire and an occlusive vessel spiral;

Figure 16 further illustrates an assembly according to an embodiment that includes an electrolytically separable joint having two thin wires and a vaso-occlusive spiral;

Figure 17 illustrates another assembly according to an embodiment that includes an electrolytically separable joint having two thin wires and a vaso-occlusive spiral;

Figure 18 illustrates an assembly according to an embodiment that includes an electrolytically separable joint having thin wires that are coiled or twisted and a vaso-occlusive spiral;

Figure 19 is a flow chart of a process that includes the delivery and separation of an implantable device by means of an electrolytically separable joint having thin wires, which are shown for the purpose of a better understanding of the invention;

Figure 20 depicts, in general, how embodiments can be used in assemblies that deliver and implant a vaso-occlusive spiral in a cranial aneurysm;

Figure 21 represents, in general, the assembly shown in Figure 20 after the electrolytic junction having thin wires has been electrolyzed to separate the vaso-occlusive spiral in the aneurysm; Y

Figure 22 is a table showing the dimensions of the various embodiments.

Detailed description of illustrated embodiments

In the following description, reference is made to the accompanying drawings that form a part thereof, and which show by way of illustration, specific embodiments in which the invention can be practiced.

Referring to Figure 1, one embodiment is directed to an assembly 100 that includes an electrolytically separable joint member 110, which is a temporary connection or sacrificial link that includes a plurality of thin or small diameter cables. The thin cables are attached to a conductive deployment mechanism 120, such as a cable, pusher, etc., and to an implantable device 130, such as a vaso-occlusive spiral. The deployment mechanism 120 is used to deliver the implantable device 130 to a treatment site, such as a cranial aneurysm. During use, after the device 130 is correctly positioned, an electric current is applied from an external power source to the conductive deployment mechanism 120 and through the connecting member 110 of thin cables and causes the formation of a thrombus in the treatment site The electric current simultaneously electrolytes and disintegrates the thin wires of the connecting member 110, thereby separating the implantable device 130 and leaving the device 130 at the treatment site and in the thrombus.

Referring to Figure 2, an assembly 200 constructed in accordance with one embodiment includes a connecting member 110 having two thin cables 210a and 210b (generally referred to as thin cables 210) extending between the deployment mechanism 120 and the implantable device 130. According to one embodiment, thin wires 210 are made of stainless steel. In an alternative embodiment, thin wires 210 are made of tungsten or other suitable materials.

As used herein, a "thin" 210 cable is defined as a cable having a small diameter, that is, from about 0.254 μm (0.00001 ") to approximately 63.5 μm (0.0025 ") for example, approximately 12.7 μm (0.0005"). According to one embodiment, such thin cables are stainless steel cables. According to one embodiment, a cross-sectional area of a thin individual cable 210 is about 50.65 x 10-10 cm2. (7.85 x 10–10 inch2) to about 31.62 x 10-5 cm2 (4.9 x 10-5 inch2) and a volume of a single cable can be from about 20.65 x 10-3 cm2 (7.85 x 10-13) to about 22.13 x 10–8 cm2 (3.43 x 10-8 inch3) .The length of a thin cable can be approximately 2.54 μm (0.01 ”) to approximately 17.72 μm (0.0007") and the length of an engraved surface of a thin cable 210 may be, for example, approximately 25.4 μm (0.001 ” ) to approximate mind 2.54 mm (0.100 ”). The dimensions of thin wires 210 may vary depending on the length of thin wire 210. For example, longer thin wires 210 may have a larger diameter. In one embodiment, a thin wire 210 having a length of about 2.54 µm (0.01 ") can be about 2.54 µm (0.0001") in diameter at about 12.7 µm ( 0.0005 ”) and a thin cable 210 having a length of approximately 7.78 μm (0.007”) can have a diameter of approximately 63.5 μm (0.0025 "). This specification refers to thin stainless steel 210 wires that have diameters ranging from approximately 0.254 μm (0.00001 ”) to approximately 63.5 μm (0.0025") to facilitate explanation, and it should be understood that Relative dimensions of the components of the assembly shown in the figures are not necessarily representative of real devices, since the relative sizes of the components have been adjusted for purposes of illustration (for example, as shown in Figure 22).

Continuing with reference to Figure 2, the proximal ends 211a, 211b (generally 211) of the respective thin cables 210a, 210b are attached to the distal end 122 of the deployment mechanism 120. The distal ends 212a, 212b (in general 212) of the thin cables 210a, 210b are attached to the proximal end 131 of the implantable device 130. The proximal ends 211 of the thin cables 210 can be attached to the distal end 122 of the deployment mechanism 120 using various known methods and materials.

Referring to Figure 3, in an assembly 300 constructed in accordance with one embodiment, the thin wires 210 are attached to the conductive deployment mechanism 120 by welding, a conductive polymer such as conductive polyacetylene, and other suitable conductive materials 310. To To facilitate the explanation, the present specification generally refers to welding 310, but embodiments can be implemented with other conductive materials that can connect the thin wires 210 to the deployment mechanism 120.

The proximal ends 211 of the thin wires 210 may come into contact with the weld 310 as in the embodiment shown in Figure 3, or they may be embedded within the weld 310. In the embodiment illustrated in Figure 3, the proximal ends 211 of the thin cables 210 are connected to the distal end 122 of the deployment mechanism 120 using welding balls 310. It should be understood that the welding balls 310 can be spherical and in other ways after the proximal ends 211 are are attached and / or embedded in the welding material 310. Figure 3 also illustrates that the distal ends 212 of the thin wires 210 may be attached to a proximal end 131 of the implantable device 130 by welding.

Referring to Figure 4, in an assembly 400 constructed in accordance with an alternative embodiment, the proximal ends 211 of the thin cables 210 may be welded 410 to the distal end 122 of the deployment mechanism 120. Figure 4 illustrates the proximal ends 211a , 212a of both thin wires 210a, 210b that are being welded 410 to the deployment mechanism 120 using a single portion of welding material or a single weld. In an alternative embodiment, thin cables 210a, 210b can be soldered separately. Figure 4 also illustrates that the distal ends 211b, 212b of the thin cables 210a, 210b may be welded 410 to a proximal end 131 of the implantable device 130.

Referring to Figure 5, in an assembly 500 constructed in accordance with another alternative embodiment, instead of joining the distal ends 212a, 212b of the thin cables 210a, 210b to the proximal end 131 of the implantable device 130 by conductive connections, such as welding 310 or welding 410, the distal ends 212a, 212b may be attached or inserted into a layer or barrier 510 of non-conductive material, such as a polymer or non-conductive glue. The non-conductive polymeric material 510 insulates the thin wires 210 of the implantable device 130. In this way, various figures illustrate that the different ends of the thin wires 210 can be connected to different components using different materials.

Figure 6 illustrates a view taken along line A-A shown in Figure 3 and illustrates that thin cables 210 may be horizontally and / or vertically offset (as illustrated) or may be vertically aligned or horizontally aligned (not shown in figure 6). In the embodiment illustrated, the proximal end of a thin cable 210a is connected to a right upper portion of the distal end 122 of the deployment mechanism 120, and another thin cable 210b is connected to a lower left portion of the distal end 122 of the mechanism deployment 120. The thin cables 210 can also be connected to other parts of the deployment mechanism 120 as necessary. In addition, it should be understood that the cross-sectional shape of the deployment mechanism 120 may be circular (as shown in Figure 5) or it may have other shapes. Furthermore, although Figure 6 illustrates an embodiment in which the thin wires 210a, 210b are connected to the distal end 122 of the deployment mechanism 120 with welding (as shown in Figure 3), the connection can be formed using other types of materials (as explained with reference to figures 4 and 5).

Figures 1-6 illustrate embodiments in which an electrolytically separable joint member 110 includes two straight thin cables 210a, 210b. During use, thin cables 210 may include several elbows and curves, for example as shown in Figure 7. Thus, the figures showing straight thin cables 210 are not intended to be limiting since thin cables 210 are flexible and foldable

In addition, Figures 1-7 illustrate embodiments in which the electrolytically separable joint member 110 includes two thin wires 210a, 210b. In alternative embodiments, the connecting member 110 may include more than two thin cables 210, for example, three thin cables, five thin cables, ten thin cables, and other numbers of thin cables 210, as necessary.

For example, in the embodiment shown in Figures 8 and 9, an assembly 800 constructed in accordance with another embodiment includes an electrolytically separable joint member 110 having four thin wires 210a-d. Figure 8 also shows separate conductive joining elements 310, for example, separate welding balls, for joining a proximal end 211 of each thin wire 210 or a group of thin wires 210 to the distal end 122 of the deployment mechanism 120.

Referring to Figures 10 and 11, in one embodiment, the electrolytically separable joint member 110 may include multiple thin wires 210 that are wound or stranded with each other 1010. According to an embodiment as shown in Figures 10 and 11, the coiled thin wires 210 have the same diameter. This configuration can be especially useful for increasing the strength and flexibility of the connecting member 110. In the embodiment illustrated, the assembly 1000 includes three thin cables 210a-c that are twisted or wound 1010 with each other. The connections at the proximal ends 211 and the distal ends 212 of the thin wires 210 have been omitted for clarity. In the illustrated embodiment, three thin wires 210 are coiled or stranded 1010, however, other numbers of thin wires 210 can be coiled or stranded 1010, including two, four, ten or other numbers of thin wires 210, as necessary. .

Referring to Figures 12 and 13, an assembly 1200 constructed in accordance with an alternative embodiment includes thin wires 210a and 210b that have different diameters and are wound or braided 1010 with each other. The connections at the proximal ends 211 and at the distal ends 212 of the thin wires 210 have been omitted again for clarity. In other embodiments, different numbers of thin wires 210 having different diameters may be wound or stranded with each other 1010. Thus, in embodiments, there may be one or more thin wires 210 of a first diameter and one or more thin wires 210 of a second diameter. There may also be one or more thin wires 210 of different numbers of diameters, for example, one or more thin wires 210 of a first diameter, one or more thin wires 210 of a second diameter, and one or more thin wires 210 of a third diameter. As a consequence, Figs. 12 and 13 are provided to illustrate various ways in which the embodiments can be implemented to form a coiled or twisted tie member 1010, including thin wires 210 of different diameters.

In addition, it should be understood that with respect to the embodiments shown in Figures 1-13, the number and arrangement of thin cables 210 may depend, for example, on the material, length, diameter (s), connections of the thin cable 210, of whether the thin cables extend freely between the deployment mechanism and the implantable device or if they are coiled or twisted and the desired tensile strength, and the desired current density of each cable 210.

Referring to Figure 14, according to another embodiment, the thin wires 210 of the connecting member 110 may be partially covered to define conductive and non-conductive sections and the points or areas of attachment. For ease of explanation and for the purpose of illustration, Figure 14 illustrates a single thin cable 210 that extends between a deployment mechanism 120 and an implantable device 130, but it should be understood that the embodiments may include several numbers of thin wires 210 which They can be coated in a similar manner.

In the embodiment illustrated, the thin wire 210 is intermittently or alternatively coated. In the illustrated embodiment, a first portion 1410 of the thin cable 210 at the proximal end 211 of the cable 210 is bare or uncoated, a second portion 1420 adjacent to the first portion 1410 is coated with a non-conductive coating 1422, a third 1430 portion adjacent to the second portion 1420 is bare, and a fourth portion 1440 at the distal end 212 of the cable 210 is coated with a non-conductive coating 1442, which may be the same or different than the non-conductive coating 1422 of the second portion 1420. The non-conductive coatings 1422 and 1442 may be, for example, a polyamide or Parylene polymer.

In the embodiment illustrated, the first portion 1410 is bare and connected to the deployment mechanism 120 with a solder 310 or other suitable conductive connection, to allow the conduction of electric current from the conductive deployment mechanism 120, through the cable thin 210 and implantable device 130. The non-conductive coatings 1422 and 1442 of the second and fourth portions 1420 and 1440 define a third bare portion 1430, which is a point or zone of separation. Thus, the fourth portion 1440 includes a non-conductive coating 1442 to define the separation zone (as explained above) and to facilitate connection to the non-conductive polymer or glue 500 that is applied to the proximal end 131 of the implantable device. 130. With this configuration, during use, the assembly is delivered to a treatment site, and the third portion 1430 is exposed to blood, which is conductive. The electric current is applied to the conductive deployment mechanism 120 and to the thin wire 210, thereby producing electrolysis and disintegration of the third portion 1430 and separation of the implantable device 130 at the treatment site.

Figure 14 shows the four different portions 1410, 1420, 1430, 1440 that have similar dimensions. However, the portions may have different lengths. For example, the first bare portion 1410 may have a length that is from about 1% to about 50% of the length of a thin wire 210, the second coated portion 1420 may have a length that is about 5% at approximately 90% of the length of a thin cable 210, the third bare portion 1430 may have a length that is about 1% to about 50% of the length of a thin cable 210, and the fourth coated portion 1440 may have a length that is about 5% to about 90% of the length of a thin wire 210.

In addition, the third bare portion 1430 may be shorter than other portions to define a point or zone of separation. The length of the first portion 1410 may be shorter depending on how much thin wire 210 is connected to the distal end 122 of the deployment mechanism 120. For example, what may be required is a short length of the first bare portion 1410, for example , a first portion 1410 that is approximately 2 mm long, or approximately 20% of the length of a thin cable 210, to allow the conductive distal end 211 to be connected to the conductive deployment mechanism 120 by means of welding 310, welding 410 or polymer conductors. As a consequence, it should be understood that different portions may have the same or similar length and different lengths, as necessary.

Referring to Fig. 15, an assembly 1500 constructed in accordance with one embodiment includes a deployment mechanism 120 that is a cable or pusher 1510, an electrolytically separable joint 110 that includes two thin cables 210a, 210b, and an implantable device 130 in Shape of a 1520 vaso-occlusive spiral, such as the vaso-occlusive spiral described in US Pat. 5,112,136 and 5,354,295. The vaso-occlusive spiral 1520 shown in Figure 15 is illustrated assuming a primary shape, that is, a linear helical shape, when introduced through a positioning catheter.

Figures 16 and 17 further illustrate embodiments of assemblies 1600 and 1700 that were made using different types of cables or pushers 1510, an electrolytically separable joint 110 and a vaso-occlusive spiral 1520. In these embodiments, thin cables 210 had a diameter of approximately 12.7 µm (0.0005 ”).

In addition, with reference to Figure 18, an assembly 1800 constructed in accordance with another embodiment includes multiple thin wires 210a-c that are coiled or twisted 1010 and a vaso-occlusive spiral 1520 (for example, as explained above with reference to figures 10-13).

A typical 1520 vaso-occlusive spiral is formed of platinum wire having a diameter of approximately 25.4 μm (0.001 ") to approximately 1.27 µm (0.005"). The primary helical shape has an internal diameter of approximately 76.2 μm (0.003 ”) to approximately 228.6 μm (0.009") and the outer diameter of the primary form is approximately 228.6 µm (0.009 ") to approximately 431.8 µm (0.017"). According to one embodiment, the Diameter of a thin stainless steel cable 210 is approximately 10-50% of the diameter of the platinum cable that is used to form the vaso-occlusive spiral.In addition, according to another embodiment, the diameter of each thin cable 210 is from about 1% to about 10% of an inner diameter of a primary form of a coiled implantable vaso-occlusive coil, therefore with a primary shape having an internal diameter of approximately 76.2 μm (0.003 ”) about At 22.86 μm (0.0009 "), the diameter of a thin wire 210 can be from approximately 0.762 μm (0.0003") to approximately 22.86 μm (0.0009 "). In addition, according to a further embodiment, the diameter of each thin wire 210 is from about 1% to about 5% of an outer diameter of a primary form of a coiled implantable vaso-occlusive spiral. Therefore, with a primary shape having an outside diameter of approximately 22.86 μm (0.009 ”) to approximately 431.8 μm (0.017"), the diameter of a thin wire 210 may be approximately 2.29 μm ( 0.00009 ”) at approximately 21.76 μm (0.0009").

Referring to Figures 19-21, for the purposes of a better understanding of the invention, a 1900 method that includes the introduction of an implantable device, such as a 1520 vaso-occlusive spiral, into a subject or patient to treat an aneurysm 2000, includes the introduction of an assembly having a vaso-occlusive spiral 1520, a conductive deployment mechanism 120, such as a cable or pusher 1510, and an electrolytically separable joint member 110 having thin cables 210, in a patient in step 1905. This can be done by introducing the assembly into the patient through a 2010 placement catheter. In step 1910, the cable or pusher 1510 is manipulated to position the spiral 1520 on or within the aneurysm 2000. Thus, as shown in Figure 20, the distal end of the placement catheter 2010 is maneuvered into the neck of aneurysm 2000. As shown in Figure 20, the sp iral 1520 assumes a primary or linear helical shape when inserted through catheter 1510, and when it exits the placement catheter 2010, spiral 1520 assumes a relaxed intricate shape, inside the aneurysm 2000. In step 1915, after that the spiral 1520 is placed and deployed in the aneurysm 2000, an electrical current 2020 is applied from a power supply 2030 external to the body 2040 and to the conductive cable 1510. The electrical current 2020 is conducted through the cable 1510 and through the thin wires 210 of the electrolytically separable junction 110 and the spiral 1520.

As a result, in stage 1920, and as shown in Figure 21, a thrombus 2100 is formed in the aneurysm after the 2000 application of electrical currents 2020. In stage 1925, after thrombus 2100 has formed, the thin wires 210 of the detachable junction 110 disintegrate, as shown in Figure 21, thereby separating the spiral 1520 in the aneurysm 2000. More particularly, the portions of the thin wires 210 that are exposed and exposed to The blood disintegrates. Thus, with reference to Figure 14, for example, the third bare portion 1430 of each thin wire 210 disintegrates, thus defining a point or zone of separation. Continuing with stage 1930, the cable 1510 and the placement catheter 2010 can be retracted, thus leaving the spiral 1520 in the aneurysm 2000. Further additional details regarding electrolytic separation are provided in US Patent No. 5,354,295.

Figures 19-21 show the delivery of a vaso-occlusive spiral 1520, but the implantable member 130 may be another implantable device 130, including a filter, such as a filter to capture embolic debris and a stent, such as an auto stent expandable, a balloon expansion stent, a coated or uncoated stent, a covered or partially covered stent, a high density brain stent or an in situ coated stent etc. In addition, the embodiments can be used to deliver an implantable device, including occlusive devices, in various vascular cavities including arteries, veins, aneurysms, vascular malformations, and arteriovenous fistulas.

In embodiments that include thin cables 210, electrolytically separable joint members 110 provide a number of improvements and advantages over electrolytically known separable joint members. For example, with the embodiments, the surface area of the joint member 110 increases substantially with respect to the surface of the known joint members, as a result of which the joint member 110 includes multiple thin wires 120. The increase in surface areas of the connecting members 110 advantageously results in reduced current densities in the connecting member 110. The reduced current densities obtained with the embodiments advantageously result in the formation and deposition of a smaller number of detachment by-products and in separation processes. more efficient In addition, the increase in surface areas obtained with the embodiments allows equal or similar current densities to be maintained while increasing the total current per mass, which improves corrosion.

For example, a cylindrical surface area of a separation zone of an electrolytically known separable device is approximately 35.48 x 10-5 cm2 (5.5 x 10-5 inch2), and the cylindrical surface area of a separation zone of an electrolytically separable joint member 110 including thin wires 210, constructed in accordance with the embodiments, may be from about 20.26 x 10-7 cm2 (3.14 x 10-7 inch2) to about 1.29 x 10- 5 cm2 (1.75 x 10-5 inch2), for example, with approximately 1 to approximately 500 thin cables 210 or more thin cables, as necessary. As a further example, the current density on electrolytically separable junction members known is approximately 3.1 x 103 mA / cm2 (2 x 104 mA / inch2), while in embodiments, the current density of the cable group Thin 120 is less than 2.07 x 103 mA / cm2 (2 x 104 mA / inch2), for example, approximately 1.03 x 103 mA / cm2 (1 x 102 mA / inch2) to approximately 2.07 x 103 mA / cm2 (2 x 102 mA / inch2).

A further improvement is that the plurality of thin cables 120 results in a lower impedance of the removable joint 110, which advantageously allows the use of lower voltages. For example, the average impedance of electrolytically known separable joint members is about 6 kOhm, and the voltage applied to a known joint member is about 6 volts. In contrast, electrolytically separable joint members 110 that include thin wires 210 according to the embodiments have lower impedances and lower voltages. For example, separable junctions 110 of thin wires 210 constructed in accordance with the embodiments may have impedances of less than 6 kOhm, for example, as low as 1 kOhm, and voltages of less than 6 volts, for example, as low as 1 volt, when a current of 1 mA is applied. The impedance and voltage may also vary depending on the joint configuration, and the impedance can be between about 1 kOhm and 10 kOhm, and the voltage can be between about 1 volt and about 10 volts when a current of approximately 1 mA

The embodiments provide additional improvements and advantages with these capabilities since lower voltages result in the generation of less noise compared to known higher voltage devices. In addition, with the less variable and lower voltage conditions obtained with the embodiments, the changes in impedance that are reflected in the voltage values are more pronounced and identifiable, which facilitates the detection of the separation and the reduction of the possibility of separation errors.

Other additional benefits that are achieved are improved strength and flexibility. The number of thin cables 120 can be selected to provide the desired strength (for example, tensile strength) and flexibility. The embodiments provide additional support when implantable device 130 is pushed and pulled through a catheter. In addition, thin cables 120 may be twisted or rolled to provide greater strength and additional support, as necessary. Thus, the embodiments advantageously provide separable joints or temporary connections that can be designed to accommodate the different requirements of flexibility and tensile strength, while reducing the current densities in the joint.

The implantable device 130 may also include a physiologically compatible radiopaque material. For example, the material may be platinum, gold, tungsten, or alloys thereof. Certain polymers are also suitable for use in implants, either alone or in conjunction with metal markers that provide radiopacity. These materials are chosen so that the procedure to locate the implant within the blood vessel can be visualized using radiography. However, it is also contemplated that the implantable device may be made of various other biologically inert polymers or carbon fiber.

Thin cables 210 having small diameters of about 0.254 µm (0.00001 ") to about 63.5 µm (0.0025") can have different lengths, cross-sectional areas, surfaces and volumes, and can form structures of cylindrical or other shape having different dimensions and volumes Figure 22 is a table 2200 that includes the dimensions of thin wire 210 of three different embodiments (represented by the rows of table 2200).

In table 2200, column 2202 represents a diameter of a single thin wire 210. In the illustrated embodiments, the diameter of thin wire 210 is 0.254 μm (0.00001 "), 12.7 μm (0.0005") and 63.5 μm (0.0025 "). Column 2204 represents a length of a single thin cable 210. In the illustrated embodiments, the length of thin cables 210 of diameter 0.254 μm (0.00001") and 12.7 μm (0.0005 ") is 2.54 μm (0.01"), and the length of thin wires 210 with a diameter of 63.5 μm (0.0025 ") is 177.80 μm (0.007") Column 2206 represents a cylindrical area or surface area of a single thin wire 210, column 2208 represents a cross-sectional area of a single thin wire 210, and column 2210 represents a volume of a single thin wire 210. The column 2212 represents a number of thin wires 2212 that can be used to form a joint member 110. In the illustrated embodiments, a joint member 110 includes 500 thin cables, another connecting member 110 includes 20 thin cables, and another connecting member 110 includes a single thin cable 210. Column 2214 represents a total cylindrical or surface area of a collection or group of thin cables 210, the column 2216 represents a cross-sectional area of a collection of thin wires 210 and column 2218 represents a volume of thin wire 210. Column 2220 represents the current densities obtained with different embodiments.

Table 210 also indicates the range of values for different dimensions, surfaces and volumes, expressed as a relationship. Thus, Figure 22 illustrates that the embodiments may include different numbers of thin cables 210, and that thin cables 210 may have different dimensions. In addition, table 2200 includes other calculations and data, for example, the dimensions of thin wires 210 in relation to the inner and outer diameters of a primary form of a vaso-occlusive spiral 1520

Claims (14)

1. A set (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800), comprising: an implantable device (130, 1520); a conductive deployment mechanism (120, 1510) to deliver the implantable device; Y an electrolytically separable joint (110) that couples the implantable device (130, 1520) to the conductive deployment mechanism (120, 1510), characterized in that the electrolytically separable joint (110) comprises a plurality of thin wires (210, 210a, 210b, 210c, 210d) that are separable from the implantable device (130, 1520) by means of the transmission of electric current (2020) therethrough.

2.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of claim 1, the thin cables (210, 210a, 210b, 210c, 210d) being configured to be electrolyzed simultaneously by a electric current (2020) applied to the conductive deployment mechanism (120, 1510).

3.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of claim 1 or 2, the thin cables (210, 210a, 210b, 210c, 210d) comprising stainless steel.

Four.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-3, comprising the plurality of thin cables (210, 210a, 210b, 210c, 210d) of Two to ten thin cables.

5.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-4, each of the thin cables having (210, 210a, 210b, 210c, 210d) a diameter between 0.0000254 cm and 0.002286 cm.

6.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-4, each of the thin cables having (210, 210a, 210b, 210c, 210d) a surface area between 5.03 mm2 and 0.00323 mm2.

7.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-6, the electrolytically separable joint (110) comprising a first plurality of thin cables (210), each having a first diameter, and a second plurality of thin cables (210), each having a second diameter different from the first diameter.

8.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-7, being coiled or stranded (1010) .the thin cables (210, 210a, 210b, 210c, 210d).

9.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-8, the thin cables (210, 210a, 210b, 210c, 210d) being connected to the mechanism of conductive deployment (120, 1510) by welding (310) or by a conductive polymer, and the thin cables (210, 210a, 210b, 210c, 210d) being connected to the implantable device (130, 1520) by a non-conductive polymer .

10.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-9, wherein, in each of the thin cables (210, 210a, 210b, 210c, 210d),

a first proximal portion (1410) of the cable is bare, a second portion (1420) adjacent to the first portion (1410) is coated with a non-conductive coating (1422), a third portion (1430) adjacent to the second portion (1420) is bare, and A fourth distal portion (1440) adjacent to the third portion (1430) is coated with a non-conductive coating (1422).

eleven.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of claim 10, wherein the respective proximal portions of the thin cables (210, 210a, 210b, 210c, 210d) they are in electrical contact with the conductive deployment mechanism (120, 1510), and the respective distal portions of the thin wires (210, 210a, 210b, 210c, 210d) are disposed within a non-conductive barrier between the electrolytically separable junction ( 110) and the implantable device (130, 1520).

12.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of any one of claims 1-4, wherein a respective diameter of each of the thin cables (210, 210a, 210b, 210c, 210d) is between 10% and 50% of a diameter of a platinum cable used to form the implantable device (130, 1520).

13.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of claim 12, with a diameter of each thin cable comprised between 0.000254 cm (0.0001 inches) and 0 .00635 cm (0.0025 inch

das), and with a diameter of the platinum cable comprising the implantable device (130, 1520) between 0.00254 cm and 0.0127 cm.

14.

The assembly (100, 200, 300, 400, 500, 800, 1200, 1500, 1700, 1800) of claim 12, the implantable device (130) comprising a vaso-occlusive spiral (1520), and in which a diameter of each thin cable is between 1% and 10% of an inner diameter of a primary spiral shape (1520), and in which a diameter of each thin cable is between 1% and 5% of an outer diameter of a primary spiral shape (1520).